Systems and methods for delivering an ocular implant to the suprachoroidal space within an eye

ABSTRACT

Delivery devices, systems and methods are provided for inserting an implant into an eye. The delivery or inserter devices or systems can be used to dispose or implant an ocular stent or implant, such as a shunt, in communication with the suprachoroidal space, uveal scleral outflow pathway, uveoscleral outflow path or supraciliary space of the eye. The implant can drain fluid from an anterior chamber of the eye to a physiologic outflow path of the eye, such as, the suprachoroidal space, uveal scleral outflow pathway, uveoscleral outflow path or supraciliary space. Alternatively, or in addition, the implant can elute a drug or therapeutic agent. The delivery or inserter devices or systems can be used in conjunction with other ocular surgery, for example, but not limited to, cataract surgery through a preformed corneal incision, or independently with the inserter configured to make a corneal incision. The implant can be preloaded with or within the inserter to advantageously provide a sterile package for use by the surgeon, doctor or operator.

RELATED APPLICATION

This patent application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/790,759, filed Mar. 15, 2013, the entirety ofwhich is hereby incorporated by reference herein.

FIELD

This disclosure generally relates to intraocular pressure reduction andmore specifically to systems, devices and methods for delivering anintraocular implant to the suprachoroidal space within an eye to treatglaucoma, ocular hypertension and/or other ocular disorders.

BACKGROUND INFORMATION

A human eye is a specialized sensory organ capable of light receptionand is able to receive visual images. Aqueous humor is a transparentliquid that fills at least the region between the cornea, at the frontof the eye, and the lens. A trabecular meshwork, located in an anteriorchamber angle, which is formed between the iris and the cornea, normallyserves as a drainage channel for aqueous humor from the anterior chamberso as to maintain a balanced pressure within the anterior chamber of theeye.

Glaucoma is a group of eye diseases encompassing a broad spectrum ofclinical presentations, etiologies, and treatment modalities. Glaucomacauses pathological changes in the optic nerve, visible on the opticdisk, and it causes corresponding visual field loss, resulting inblindness if untreated. Lowering intraocular pressure is a majortreatment goal in all glaucomas.

In glaucomas associated with an elevation in eye pressure (intraocularhypertension), a main source of resistance to outflow is typically inthe trabecular meshwork. The tissue of the trabecular meshwork normallyallows the aqueous humor (hereinafter also referred to as “aqueous”) toenter Schlemm's canal, which then empties into aqueous collectorchannels in the posterior wall of Schlemm's canal and then into aqueousveins, which form the episcleral venous system. Aqueous is continuouslysecreted by ciliary bodies around the lens, so there is a constant flowof aqueous from the ciliary body to the anterior chamber of the eye.Pressure within the eye is determined by a balance between theproduction of aqueous and its exit through the trabecular meshwork(major route) and uveoscleral outflow (minor route) pathways. Theportion of the trabecular meshwork adjacent to Schlemm's canal (thejuxtacanilicular meshwork) can cause most of the resistance to aqueousoutflow.

While a majority of the aqueous leaves the eye through the trabecularmeshwork and Schlemm's canal, it is believed that at least about 10 toabout 20 percent of the aqueous in humans leaves through the uveoscleralpathway. The degree with which uveoscleral outflow contributes to thetotal outflow of the eye appears to be species dependent. As usedherein, the term “uveoscleral outflow pathway” is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and it is not to be limited to a special or customized meaning), andrefers without limitation to the space or passageway whereby aqueousexits the eye by passing through the ciliary muscle bundles located ator near an angle of the anterior chamber and into the tissue planesbetween the choroid and the sclera, which extend posteriorly to theoptic nerve. From these tissue planes, it is believed that the aqueoustravels through the surrounding scleral tissue and drains via thescleral and conjunctival vessels, or is absorbed by the uveal bloodvessels.

It is unclear from studies whether the degree of physiologic uveoscleraloutflow is pressure-dependent or pressure-independent. As used herein,the temrm “supraciliary space” is to be given its ordinary and customarymeaning to a person of ordinary skill in the art (and it is not to belimited to a special or customized meaning), and refers withoutlimitation to the portion of the uveoscleral pathway through the ciliarymuscle and between the ciliary body and the sclera, and the term“suprachoroidal space” is to be given its ordinary and customary meaningto a person of ordinary skill in the art (and it is not to be limited toa special or customized meaning), and refers without limitation to theportion of the uveoscleral pathway between the choroid and sclera.

Glaucoma is broadly classified into two categories: closed-angleglaucoma, also known as angle closure glaucoma, and open-angle glaucoma.Closed-angle glaucoma is caused by closure of the anterior chamber angleby contact between the iris and the inner surface of the trabecularmeshwork. Closure of this anatomical angle prevents normal drainage ofaqueous from the anterior chamber of the eye.

Open-angle glaucoma is any glaucoma in which the exit of aqueous throughthe trabecular meshwork is diminished while the angle of the anteriorchamber remains open. For most cases of open-angle glaucoma, the exactcause of diminished filtration is unknown. Primary open-angle glaucomais the most common of the glaucomas, and is often asymptomatic in theearly to moderately advanced stages of glaucoma. Patients may suffersubstantial, irreversible vision loss prior to diagnosis and treatment.

Most current therapies for glaucoma are directed toward decreasingintraocular pressure. Medical therapy includes topical ophthalmic dropsor oral medications that reduce the production of aqueous or increasethe outflow of aqueous. However, drug therapies for glaucoma aresometimes associated with significant side effects. The most frequentand perhaps most serious drawback to drug therapy, especially theelderly, is patient compliance. Patients often forget to take theirmedication at the appropriate times or else administer eye dropsimproperly, resulting in under- or overdosing. Patient compliance isparticularly problematic with therapeutic agents requiring dosingfrequencies of three times a day or more, such as pilocarpine. Becausethe effects of glaucoma are irreversible, when patients dose improperly,allowing ocular concentrations to drop below appropriate therapeuticlevels, further permanent damage to vision occurs. Furthermore, currentdrug therapies are targeted to be deposited directly into the ciliarybody where the aqueous is produced. And current therapies do not providefor a continuous slow-release of the drug. When drug therapy fails,surgical therapy is pursued.

Surgical therapy as currently pursued suffers from many disadvantages.These include, a proper protocol for the medical practitioner to followso as to introduce a suprachoroidal implant on a patient's eye without.Additionally, such a surgical procedure can involve many pre- andpost-operative procedures which can add to overall inefficiency andcause the operation to involve a significant amount of costs. As such,making it harder for a patient to undertake such a surgery andreluctance on the part of the doctor to prescribe same.

SUMMARY

As such, a need exists for a more facile, convenient, less invasive, andless traumatic means of delivering an intraocular pressure controllingimplant into an eye while providing a cost-effective but safe surgicalprocedure. It is one advantage of certain embodiments of theinvention(s) disclosed herein to provide delivery devices, systems andmethods are provided for inserting an implant into an eye. The deliveryor inserter devices or systems can be used to dispose or implant anocular stent or implant, such as a shunt, in communication with thesuprachoroidal space, uveal scleral outflow pathway, uveoscleral outflowpath or supraciliary space of the eye. The implant can drain fluid froman anterior chamber of the eye to a physiologic outflow path of the eye,such as, the suprachoroidal space, uveal scleral outflow pathway,uveoscleral outflow path or supraciliary space. Alternatively, or inaddition, the implant can elute a drug or therapeutic agent. Thedelivery or inserter devices or systems can be used in conjunction withother ocular surgery, for example, but not limited to, cataract surgerythrough a preformed corneal incision, or independently with the inserterconfigured to make a corneal incision. The implant can be preloaded withor within the inserter to advantageously provide an operator friendlypackage, such as a sterile package, for use by the surgeon, doctor oroperator.

As used herein, “implants” refers to ocular implants which can beimplanted into any number of locations in the eye. In some embodiments,the ocular implants are drainage implants designed to facilitate orprovide for the drainage of aqueous humor from the anterior chamber ofan eye into a physiologic outflow pathway in order to reduce intraocularpressure. In some embodiments, the implant can be configured to providea fluid flow path for draining aqueous humor from the anterior chamberto a uveoscleral outflow pathway. In some embodiments, the aqueous humoris diverted to the supraciliary space or the suprachoroidal space of theuveoscleral outflow pathway.

The term “implant” as used herein is a broad term, and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and it is not to be limited to a special or customized meaning),and refers without limitation to drainage shunts, stents, sensors, drugdelivery implants, drugs, therapeutic agents, fluids, or any otherdevice or substance capable of being permanently or temporarily insertedwithin an eye and left within a body after removal of a deliveryinstrument.

If desired, more than one implant of the same or different type may beimplanted. For example, the implants disclosed herein may be used incombination with trabecular bypass shunts, such as those disclosed inU.S. Patent Publication 2004/0050392, and those described in U.S. PatentPublication 2005/0271704, filed Mar. 18, 2005. Additionally,implantation may be performed in combination with other surgicalprocedures, such as cataract surgery. All or a portion of the implantmay be coated, e.g. with heparin, preferably in the flow path, to reduceblood thrombosis or tissue restenosis.

Certain embodiments of some of the inventions disclosed, taught orsuggested herein are set forth in the appended claims.

For purposes of summarizing embodiments of the invention(s), certainaspects, advantages and novel features of the invention have beendescribed herein above. Of course, it is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment of the invention. Thus, the invention may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught or suggested herein withoutnecessarily achieving other advantages as may be taught or suggestedherein.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments of the inventionwill become readily apparent to those skilled in the art from thefollowing detailed description of the preferred embodiments havingreference to the attached figures, the invention not being limited toany particular preferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus summarized the general nature of some of the embodiments ofthe invention(s) and some of their features and advantages, certainpreferred embodiments and modifications thereof will become apparent tothose skilled in the art from the detailed description herein havingreference to the figures that follow, which are intended to illustrateand not to limit the disclosure.

FIG. 1 is a simplified schematic sectional view of a portion of an eyeillustrating certain ocular anatomical features thereof and therein.

FIG. 2 is a simplified perspective view of an implant delivery orinserter system or device, preloaded with an ocular implant,illustrating features and advantages in accordance with certainembodiments. FIG. 2A is a close-up perspective view of the ocularimplant loaded on the implant delivery or inserter system or device ofFIG. 2.

FIG. 3 is a simplified exploded perspective view of the implant deliveryor inserter system or device of FIG. 2 illustrating features andadvantages in accordance with certain embodiments.

FIG. 4 is a simplified partially cut-off side view of the implantdelivery or inserter system or device of FIG. 2 illustrating featuresand advantages in accordance with certain embodiments.

FIG. 5 is a simplified side view of an ocular implant, stent or shuntillustrating features and advantages in accordance with certainembodiments.

FIG. 6 is a simplified bottom or lower view of the ocular implant, stentor shunt of FIG. 5 illustrating features and advantages in accordancewith certain embodiments.

FIG. 7 is a simplified top or upper view of the ocular implant, stent orshunt of FIG. 5 illustrating features and advantages in accordance withcertain embodiments.

FIG. 8 is a simplified sectional view along line 8-8 of the ocularimplant, stent or shunt of FIG. 7 illustrating features and advantagesin accordance with certain embodiments.

FIG. 9 is a simplified side view of an insertion sleeve, tube or needleof the implant delivery or inserter system or device of FIG. 2illustrating features and advantages in accordance with certainembodiments.

FIG. 10 is a simplified perspective view of an insertion sleeve, tube orneedle device or assembly of the implant delivery or inserter system ordevice of FIG. 2, including the insertion sleeve, tube or needle of FIG.9, illustrating features and advantages in accordance with certainembodiments.

FIG. 11 is a simplified side view of the insertion sleeve, tube orneedle device or assembly of FIG. 10 illustrating features andadvantages in accordance with certain embodiments.

FIG. 12 is a simplified perspective of a trocar device or assembly ofthe implant delivery or inserter system or device of FIG. 2 illustratingfeatures and advantages in accordance with certain embodiments.

FIG. 13 is a simplified side view of the trocar device or assembly ofFIG. 12 illustrating features and advantages in accordance with certainembodiments.

FIG. 14 is a simplified distal end view of the trocar device or assemblyof FIG. 12 illustrating features and advantages in accordance withcertain embodiments.

FIG. 15 is a simplified proximal end view of the trocar device orassembly of FIG. 12 illustrating features and advantages in accordancewith certain embodiments.

FIG. 16 is a simplified perspective view of a trocar trigger of theimplant delivery or inserter system or device of FIG. 2 illustratingfeatures and advantages in accordance with certain embodiments.

FIG. 17 is a simplified perspective view of a safety clip of the implantdelivery or inserter system or device of FIG. 2 illustrating featuresand advantages in accordance with certain embodiments.

FIG. 18, FIG. 19, FIG. 20, FIG. 21 and FIG. 22 are simplified schematicviews illustrating a surgical procedure or method of implanting anocular implant in the suprachoroidal space of an eye using the implantdelivery or inserter system or device of FIG. 2, having features andadvantages in accordance with certain embodiments, wherein: FIG. 18illustrates insertion of the implant and the delivery or inserter systemor device into an anterior chamber of the eye; FIG. 19 illustratespositioning of the implant at the implantation site; FIG. 20 illustratesadvancement and implantation of the implant in the suprachoroidal space;FIG. 21 illustrates retraction of a trocar of the delivery or insertersystem or device from the suprachoroidal space; and FIG. 22 illustratesthe removal of the delivery or inserter system or device from theanterior chamber of the eye with the implant remaining within the eye.

FIG. 23 is a simplified perspective view of an implant delivery orinserter system or device, preloaded with an ocular implant,illustrating features and advantages in accordance with certainembodiments.

FIG. 24 is a simplified exploded perspective view of the implantdelivery or inserter system or device, including the implant, of FIG. 23illustrating features and advantages in accordance with certainembodiments.

FIG. 25 is a simplified side view of a penetration needle, sleeve ortube of the implant delivery or inserter system or device of FIG. 23illustrating features and advantages in accordance with certainembodiments.

FIG. 26 is a simplified bottom or lower view of the penetration needle,sleeve or tube of FIG. 25 illustrating features and advantages inaccordance with certain embodiments.

FIG. 27 is a simplified perspective view of a penetration needle, sleeveor tube device or assembly of the implant delivery or inserter system ordevice of FIG. 23, including the penetration needle, sleeve or tube ofFIG. 25, illustrating features and advantages in accordance with certainembodiments.

FIG. 28 is a simplified side view of the penetration needle, sleeve ortube device or assembly of FIG. 27 illustrating features and advantagesin accordance with certain embodiments.

FIG. 29 is a simplified top or upper view of the penetration needle,sleeve or tube device or assembly of FIG. 27 illustrating features andadvantages in accordance with certain embodiments.

FIG. 30 is a simplified sectional view along line 30-30 of FIG. 29illustrating features and advantages in accordance with certainembodiments.

FIG. 31 is a simplified perspective view of a trocar device or assemblyof the implant delivery or inserter system or device of FIG. 23illustrating features and advantages in accordance with certainembodiments.

FIG. 32 is a simplified side view of the trocar device or assembly ofFIG. 31 illustrating features and advantages in accordance with certainembodiments.

FIG. 33 is a simplified perspective view of a trocar trigger of theimplant delivery or inserter system or device of FIG. 23 illustratingfeatures and advantages in accordance with certain embodiments.

FIG. 34 is a simplified perspective view of a pusher tube device orassembly of the implant delivery or inserter system or device of FIG. 23illustrating features and advantages in accordance with certainembodiments.

FIG. 35 is a simplified side view of the pusher tube device or assemblyof FIG. 34 illustrating features and advantages in accordance withcertain embodiments.

FIG. 36 is a simplified perspective view of a pusher tube trigger of theimplant delivery or inserter system or device of FIG. 23 illustratingfeatures and advantages in accordance with certain embodiments.

FIG. 37 is a simplified perspective detail view from FIG. 24 of theengagement between a collar of the trocar assembly and the trocartrigger and between a collar of the pusher tube assembly and the pushertube trigger illustrating features and advantages in accordance withcertain embodiments.

FIGS. 38A and 38B are simplified perspective views of a distal end ofthe implant delivery or inserter system or device of FIG. 23 (withoutthe cover) showing the trocar and pusher tube positioning at differentpositions of the trocar and pusher tube triggers illustrating featuresand advantages in accordance with certain embodiments.

FIG. 39, FIG. 40, FIG. 41, FIG. 42, FIG. 43 and FIG. 44 are simplifiedschematic views illustrating a surgical procedure or method ofimplanting an ocular implant in the suprachoroidal space of an eye usingthe implant delivery or inserter system or device of FIG. 23, havingfeatures and advantages in accordance with certain embodiments, wherein:FIG. 39 illustrates insertion of the implant and the delivery orinserter system or device into an anterior chamber of the eye through anincision made by an insertion needle of the delivery or inserter systemor device; FIG. 40 illustrates deployment of a trocar and a pusher tubeof the delivery or inserter system or device such that the implant isexposed within the anterior chamber; FIG. 41 illustrates positioning ofthe implant at the implantation site; FIG. 42 illustrates advancementand implantation of the implant in the suprachoroidal space; FIG. 43illustrates retraction of a trocar of the delivery or inserter system ordevice from the suprachoroidal space; and FIG. 44 illustrates theremoval of the delivery or inserter system or device from the anteriorchamber of the eye with the implant remaining within the eye.

DETAILED DESCRIPTION

The preferred embodiments of the invention described herein relategenerally to intraocular pressure reduction and, in particular, tosystems, devices and methods for delivering an intraocular implant tothe suprachoroidal space, supraciliary space or other anatomical spacewithin an eye to treat glaucoma, ocular hypertension and/or other oculardisorders.

While the description sets forth various embodiment specific details, itwill be appreciated that the description is illustrative only and shouldnot be construed in any way as limiting the invention. Furthermore,various applications of the invention, and modifications thereto, whichmay occur to those who are skilled in the art, are also encompassed bythe general concepts described herein.

FIG. 1 shows relative anatomical features of an eye 10. These include ananterior chamber 32 and a sclera 38 which is a thick collagenous tissuethat covers the entire eye 10 except a portion that is covered by acornea 36. The cornea 36 is a thin transparent tissue that focuses andtransmits light into the eye and through a pupil 42, which is agenerally circular hole in the center of an iris 44 (colored portion ofthe eye), to a lens 48. The cornea 36 merges into the sclera 38 at ajuncture referred to as a limbus 45. Ciliary bodies 46 are vasculartissue that extend along the interior of the sclera 38 from the outeredges of the iris in the limbal region to a choroid 40.

The anterior chamber 32 of the eye 10, which is bound anteriorly by thecornea 36 and posteriorly by the iris 44 and the lens 48, is filled withaqueous humor, aqueous fluid or simply referred herein as aqueous.Aqueous is produced primarily by the ciliary bodies 46 and flows intothe posterior chamber, bounded posteriorly by the lens 48 and anteriorlyby the iris 44. The aqueous humor then flows anteriorly through thepupil 42 and into the anterior chamber 32 until it reaches an anteriorchamber angle 50, formed generally between the iris 44 and the cornea36.

In a normal eye, at least some of the aqueous humor drains from theanterior chamber 32 through a trabecular meshwork into Schlemm's canaland thereafter through a plurality of collector ducts and aqueous veins,which merge with blood-carrying veins, and into systemic venouscirculation. Intraocular pressure is maintained by an intricate balancebetween secretion and outflow of aqueous humor in the manner describedabove. Glaucoma is, in most cases, characterized by an excessive buildupof aqueous humor in the anterior chamber 32, which leads to an increasein intraocular pressure. Fluids are relatively incompressible, and thusintraocular pressure is distributed relatively uniformly throughout theeye 10.

The choroid 40 is a vascular layer of the eye 10 located between thesclera 38 and a retina (not shown). An optic nerve (not shown) transmitsvisual information to the brain and is the anatomic structure that isprogressively destroyed by glaucoma, ocular hypertension, and/or otherocular or ophthalmic disorders.

Another naturally existing aqueous drainage route is provided through asuprachoroidal space, supraciliary space, uveal scleral outflow path orpathway or uveoscleral outflow path or pathway 34 which is a space orregion generally defined between the sclera 38 and the choroid 40. Thesuprachoroidal space 34 is exposed to the anterior chamber 32 throughthe anterior chamber angle 50. The tissue connection between theanterior chamber 32 and suprachoroidal space 34 is generally via afibrous attachment zone 60 generally disposed between a scleral spur 62and iris processes 64 and/or ciliary muscle 66 which is a part of thechoroid 40.

Certain embodiments of suprachoroidal implants, delivery devices,associated components and suprachoroidal implantation methods andprocedures, and the like, among others, are disclosed in U.S. PatentApplication Publication No. 2008/0228127 A1, published Sep. 18, 2008, toBurns et al., and assigned to Glaukos Corporation of Laguna Hills,Calif., the entire content of which is incorporated herein by reference.

Delivery Device for Advancing Implant Through Pre-Formed CornealIncision

FIGS. 2-4 show different views of an implant delivery or insertersystem, instrument or device 110, preloaded with an ocular implant 120,in accordance with some embodiments. The delivery device 110 isconfigured to implant the implant 120 in the suprachoroidal space 34 ofthe eye 10. In some embodiments, the delivery method is an ab internoprocedure. In some embodiments, the implant delivery procedure isperformed in combination with other ocular surgery, such as, cataractsurgery, and the implant is delivered through a preformed cornealincision.

The implant preloaded delivery device 110 can be provided in a sterilepackaging for single-use operation. For example, a double polythene bagmay be used for sterility purposes, in combination with a blisterpackaging to facilitate use by the operator while still maintaining safeusage.

The delivery device 110 is generally elongate in structure, andgenerally comprises an outer housing and handpiece 122, an implantretainer 124, an insertion sleeve, tube or needle device or assembly126, a trocar device or assembly 128, a trocar trigger 130, a triggersafety clip or device 132 and a pair of solid glue preform structures134 a and 134 b.

The outer housing 122 encloses various componentry of the deliverydevice 110 and can comprise two housing portions such as a left housingportion 136 a and a right housing portion 136 b, which can be attachedduring fabrication of the delivery device 110.

Selected portions of the housing 122 have ergonomic features such as thehand grip area 138 a which has a ribbed texture or the like tofacilitate manual handling by a surgeon, medical operator orpractitioner (a similar hand grip area is provided on the right housingportion 136 b). Various internal structures of the outer housing 122engage the other components of the delivery device 110, as discussedfurther below.

The outer housing 122 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the outer housing 122 comprises a thermoplastic materialsuch as medical grade polycarbonate (PC) that is gamma stable.

The outer housing 122 can efficaciously be dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the outer housing 122 has a length of about 5.60 inches,though other lengths may also be efficaciously utilized, for example,based on the size of the user's hand (e.g., between about 4 inches andabout 8 inches or any length in between).

The implant retainer 124 (see FIG. 2) is a generally disc shapedstructure that is removably mounted on a distal tip of the trocar device128 just distally of the implant 120. The implant retainer 124 isremoved before the delivery device 110 is used. The implant retainer 124may prevent undesirable movement of the implant 120 and prevent theimplant 120 from sliding off the distal tip of the trocar device 128during packaging, shipping and travel of the implant preloaded deliverydevice 110.

The implant retainer 124 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the implant retainer 124 comprises molded silicone.

The insertion sleeve, tube or needle device or assembly 126 generallycomprises an insertion sleeve, tube or needle 140 and a support sleeve,member or element 142 fixedly attached thereto and to the outer housing122. Distal portions of the insertion sleeve or needle 140 and supportmember or element 142 are exposed and extend beyond the distal tip ofthe delivery device 110 while proximal portions of the insertion sleeveor needle 140 and support member or element 142 are contained within theouter housing 122. The insertion sleeve device 126 is discussed infurther detail later herein.

The trocar device or assembly 128 generally comprises a trocar 144 and atrocar clip or support member or element 146 attached thereto. Thetrocar clip 146 is mechanically coupled, connected or attached to theactuatable trocar trigger 130. A substantial portion of the trocar 144extends through the insertion sleeve 140 with a distal portion extendingbeyond the insertion sleeve 140 on which the implant 120 is located. Aproximal portion of the trocar 144 and the trocar clip 146 are containedwithin the outer housing 122. The trocar device 128 is discussed infurther detail later herein.

The trocar trigger 130 generally comprises an upper finger or thumbactuatable portion 148 and a lower main body portion 150. The actuatabletrigger portion 148 generally extends above the housing 122 while themain body portion 150 is generally contained within the housing 122.Before use, the trocar trigger 130 is in a forward position and when inuse it is utilized to retract the trocar 144. The trigger main bodyportion 150 is mechanically coupled, connected or attached to the trocardevice 128. The trocar trigger 130 is discussed in further detail laterherein.

The trigger safety clip 132 is removable and is positioned generallyrearwardly with respect to the trocar trigger 130 and is mechanicallycoupled or engaged with the trocar trigger 130. The trigger safety clip132 prevents undesirable motion of the trocar trigger 130 duringpackaging, shipping and travel of the implant preloaded delivery device110, as also discussed further below.

The glue blocks or preforms 134 a and 134 b are mounted on each side ofthe trocar trigger 130 and within the outer housing 122. The glue blocksor structures 134 a and 134 b may advantageously provide a safetyfunction to disallow reuse of the delivery device 110 so as to preventany cross-contamination between unauthorized reuse of the single usedevice 110. As discussed further below, the glue blocks 134 a and 134 bcan be configured to melt, dissolve or otherwise shrink or disappearwhen any unapproved re-sterilization of the delivery device 110 isattempted and lock or jam the trocar trigger 130 so that its movement isthwarted. In some embodiments, a hot melt adhesive is used to freeze thetrigger mechanism and prevent use after autoclave.

FIGS. 5-8 show different views of the ocular implant, stent or shunt 120in accordance with some embodiments. The implant 120 generally comprisesan elongate implant body 151 and a proximal implant sleeve 152. Theimplant 120 and/or the implant body 151 comprises a lumen, channel,pathway or passage 154 extending therethrough for drainage of fluid oraqueous from the anterior chamber 32 to the suprachoroidal space 34 anda plurality of generally circumferential retention features orstructures, ribs, rings or anchors 156 to facilitate implantation andretention and/or stability in the suprachoroidal space 34. In theillustrated embodiment, the implant 120 comprises four retentionfeatures; however, other numbers of retention features may be used.

The implant 120 and/or the implant body 151 further comprises respectivedistal and proximal ribs, flanges or stops 158 and 160 which hold thesleeve 152 in place. Moreover, the proximal structure 160 is dimensionedso that the implant cannot move rearwardly with respect to the distalend of the insertion sleeve 140.

Advantageously, the implant 120 and/or the implant body 151 has apredetermined curvature and/or flexibility that substantially matchesand/or allows for proper insertion in the suprachoroidal space 34. Thelumen 154, in accordance with certain embodiments, allows for drainageor flow of fluid or aqueous from the anterior chamber 32 to thesuprachoroidal space 34. The length of the implant 120 can range fromabout 1 mm to about 8 mm (e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7mm, 8 mm).

The implant 120 can efficaciously be fabricated from various suitablematerials, as required or desired. In one non-limiting embodiment, theimplant body 151 comprises a plastic, such as polyethersulfone (PES),and the sleeve 152 comprises a metal or alloy, such as titanium or atitanium alloy. In some embodiments, the sleeve 152 provides a visualaid in determining the proper depth of stent placement duringimplantation (e.g., radiopaque marker).

The implant 120, in some embodiments, can also comprise a therapeuticagent or drug. For example, at least a portion of the implant 120 iscoated with a therapeutic agent or drug. In one embodiment, at least theimplant lumen 154 is coated with a therapeutic agent or drug, such as,but not limited to, heparin or the like.

The implant 120 can be efficaciously dimensioned in various suitablemanners, as required or desired. In one non-limiting embodiment, theradius of curvature R₈ is about 1 inch, the diameter D₈ is about atleast 0.0063 inches, and the diameter D₅ is about at least 340 microns.The implant 120 can be symmetrically designed such that it may be usedin either the left or right eye. Other implants can be delivered by thedelivery devices 110, 210 in addition to the implant 120.

FIGS. 9-11 show different views of the insertion sleeve, tube or needledevice or assembly 126 and insertion sleeve, tube or needle 140 inaccordance with some embodiments. The insertion sleeve 140 is agenerally elongated tubular structure with a lumen 162 extendingtherethrough and a distal curved or non-linear portion 164 to desirablyfacilitate ab interno suprachoroidal implantation.

The insertion sleeve support 142 is an elongated member through which aportion of the sleeve 140 extends and is fixedly attached thereto. Theinsertion sleeve support 142 includes a collar 166 which mates with acorresponding portion of the outer housing 122 to fixedly attach thesestructures.

The insertion sleeve 140 receives a portion of the trocar 144 whichpasses through the sleeve lumen 162. The sleeve distal curved ornon-linear portion 164 advantageously provides proper curvature andalignment of the trocar 144 and/or the implant 120 for suprachoroidalimplantation.

The insertion sleeve device 126 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the insertion sleeve 140 and sleeve support 142 comprise aliquid crystal polymer or thermoplastic such as polycarbonate which aremolded to form the assembly. In another non-limiting embodiment, theinsertion sleeve 140 and sleeve support 142 comprise stainless steel andare welded (spot or continuous) to form the assembly. The insertionsleeve 140 can efficaciously comprise 26±5 gauge hypodermic tubing, asrequired or desired, including 21, 22, 23, 24, 25, 26, 27, 28, 29, 30and 31 gauge.

The insertion sleeve device 126 can be efficaciously dimensioned invarious suitable manners, as required or desired. In one non-limitingembodiment, the length L₉₁ is about 1.8 inches, the length L₉₂ is about0.06 inches, the diameter D₉₁ is about 0.018 inches, the diameter D₉₂ isabout 0.001 inches, the radius of curvature R₉ is about 0.11 inches, andthe angle θ₉ is about 28° (degrees).

FIGS. 12-15 show different views of the trocar device or assembly 128,in accordance with some embodiments. The trocar 144 is a generallyelongated structure with a curved or non-linear distal portion 168 witha distal-most end 170 that is configured to optimally penetrate oculartissue so as to access the suprachoroidal space 34.

The trocar 144 extends through the trocar clip 146 which is configuredto engage the trocar trigger 130, and be retractable on actuation of thetrigger 130. The curved distal portion 168 may have a predeterminedcurvature to allow a proper angle of attack to penetrate ocular tissueto provide access for implantation of the implant 120 in thesuprachoroidal space 34.

In some embodiments, the trocar clip 146 is configured to mechanicallyengage, couple, connect or fixedly attach to a recessed portion of thetrocar trigger 130. Thus, actuation or retraction of the trocar trigger130 results in movement and retraction of the trocar 144.

The trocar device 128 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar 144 comprises a metal or metal alloy such asspring tempered 304 stainless steel with a predetermined flexibility andresilience, and the trocar clip 146 comprises a metal or metal alloysuch as 301 stainless steel with a predetermined hardness. The trocar144 and trocar clip 146 can be welded together, such as, denoted by weldspots 172, or otherwise attached in other suitable manners, for examplemolding and the like, as needed or desired.

The trocar device 128 can be efficaciously dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the radius of curvature R₁₃ of the trocar distal curvedportion 168 is about 1 inch (which generally conforms to the implant'sradius of curvature and may prevent implant creep), the diameter D₁₃ isabout 0.006 inches (which provides a low tolerance fit within theimplant's lumen), the length L₁₃ is about 0.17 inches, the overallunbent length of the trocar 144 is about 2.3 inches, and the radius ofcurvature of the trocar distal end tip 170 is in the range from about0.001 to about 0.003 inches. In various embodiments, the radius ofcurvature R₁₃ of the trocar distal curved portion 168 can range from 0.4inches to about 2.2 inches.

FIG. 16 shows a different view of the trocar trigger 130, in accordancewith some embodiments. The ergonomic upper finger or thumb touch portion148 has a ribbed texture configuration to facilitate its actuation bythe operator. The lower main body portion 150 has several features thatallow for the operation of the trocar trigger 130.

The trigger body portion 150 comprises a slot, cavity, opening orrecessed portion 171 which mates with and attaches to a portion of thetrocar clip 146 thereby effectively coupling and connecting the trigger130 and the trocar 144. The trigger body portion 150 also comprisesmultiple pins 174 disposed generally symmetrically on either side whichslidably engage the internal structure of the housing 122 such as theleft and right slots therein, one of which slots is depicted byreference numeral 178 b in FIGS. 3 and 4.

The trigger body portion 150 further comprises slots 176 on each sidewhich respectively receive the glue preformed blocks 134 a and 134 bthat are mounted therein. As noted above, and discussed further herein,these glue blocks can be configured to melt, dissolve, or otherwiseshrink or disappear and lock the trigger 130 to prevent unapproved usefor the safety of the patient. Other reuse prevention mechanisms mayalso be used. In some embodiments, a hot melt adhesive is used to freezethe trigger mechanism and prevent use after autoclave.

The trocar trigger 130 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar trigger 130 comprises a plastic or thermoplastic,such as polyethylene.

FIG. 17 shows a different view of the removable trigger safety clip 132,in accordance with some embodiments. A safety clip upper portion 178 isexposed above the housing 122 and a safety clip lower portion 180 iscontained within the housing 122.

As noted earlier, the trigger safety clip 132 prevents undesirablemotion of the trocar trigger 130 during packaging, shipping and travelof the implant preloaded delivery device 110. The safety clip lowerportion 180 is engaged with the trocar trigger 130 prior to use of thedelivery device 110 and, by manipulation of the safety clip upperportion 178, the trigger safety clip 132 is removed from the deviceprior to the surgical procedure.

The safety clip 132 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the safety clip 132 comprises a thermoplastic such as apolycarbonate, for example, Makrolon® 2458.

The delivery device 110 generally comprises, but is not limited to,materials composed of stainless steel, molded plastic and silicone,among others and equivalents thereof.

Methods of Implant Delivery Through Pre-Formed Corneal Incision

FIGS. 18-22 show some steps or acts of a surgical procedure or method ofimplanting the ocular implant 120 in the suprachoroidal space 34 of theeye 10 using the implant delivery or inserter system or device 110 inaccordance with some embodiments. Given the details in the figures thesurgical method should be self-explanatory, however some textualdescription is provided below.

A cohesive viscoelastic is added to the anterior chamber, as needed, tomaintain IOP for use of a gonioprism (surgeons may select a cohesiveviscoelastic of their preference, including but not limited to, Healon,Amvisc or Provisc) through the incision created for implant or stentimplantation or cataract surgery, as noted further below.

The gonioprism is placed on the cornea. The surgical microscope andpatient are positioned to provide clear visualization of the trabecularmeshwork on the nasal side of the eye through the gonioprism. Thepatient's head is tilted as far as practical away from the surgeon, andthe microscope is tilted toward the surgeon to ensure a proper viewingangle.

The anterior chamber angle is inspected using the gonioprism to ensuregood visualization at the nasal implant location.

The implant preloaded delivery device 110 is removed from the blistertray and the implant retainer 124 is removed from the implant distal endor tip and trocar tip under the microscope (e.g., using fine forceps)without disrupting the implant position and taking care that the implant120 does not slide off the trocar 144.

The safety clip 132 is then removed, taking care once again that theimplant 120 does not slide off the trocar 144, and that the trocartrigger 130 is maintained in the forward position by the operator, anddoes not slide rearward.

If required, the anterior chamber can be deepened by injectingadditional cohesive viscoelastic into the anterior chamber to aid inchamber maintenance. The inserter tip can be coated with a small drop ofviscoelastic, as required.

In accordance with some embodiments, the implantation surgery isperformed in conjunction with another ophthalmic procedure, such ascataract surgery, and as illustrated in FIG. 18, the delivery instrument110 with the implant 120 preloaded thereon at a distal portion thereofis introduced or inserted into the anterior chamber 32 through apreexisting or preformed corneal incision 70. The insertion sleeve orneedle 140 extends through the incision 70 and into the anterior chamber32. The trocar trigger 130 is maintained in the forward position by theoperator. The delivery device 110 is advanced to the papillary marginbefore replacing the gonioprism onto the eye. In some embodiments, careis taken to avoid contact with the lens 48, cornea 36 and iris 44.

As illustrated in FIG. 19, the implant 120 is advanced across theanterior chamber 32 to the anterior chamber angle 50 towards the scleralspur 62, and positioned at the implantation site with the trocar distalend 170 adjacent the fibrous attachment zone 60. The trocar trigger 130is maintained in the forward position by the operator. In accordancewith some embodiments, the angle of attack θ₁₉ is about 15° (degrees),though 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20° (degrees) or otherattack angles may efficaciously be utilized, as needed or desired.

Next, as illustrated in FIG. 20, the trocar distal tip or end 170penetrates through the tissue of and/or adjacent the fibrous attachmentzone 60 and the implant 120 is advanced until its implantation positionhas been reached in the suprachoroidal space 34 with a predeterminedportion of the implant sleeve 152 extending into the anterior chamber32. The trocar trigger 130 is maintained in the forward position by theoperator. (Stated differently, a generally narrow passage is createdinto the suprachoroidal space by gently separating the iris processesaway from the scleral spur with the tip of the insertion trocar untilthe anterior and posterior portions of the scleral spur aresubstantially fully visible on a limited area—e.g., create anapproximately 0.5 mm to a maximum of about 1 mm width opening. Theimplant or stent is then advanced until the anterior surface of theimplant or stent is substantially tangent to the posterior margin of thescleral spur. With finger or thumb firmly on the trocar trigger in theforward position, the trocar/implant are carefully advanced into thesuprachoroidal space until the implant proximal sleeve just passes thescleral spur and enters the suprachoroidal space—in some embodiments,approximately half (or about 0.4 mm to about 0.7 mm) of the implantsleeve remains in the anterior chamber.

Next, as illustrated in FIG. 21, the trocar trigger 130 is moved in arear or proximal direction 182 by the operator so that the trocar 144 isretracted from the implant lumen 154 and the suprachoroidal space 34.(Stated differently, once the implant or stent is in position at theproper depth, the trocar trigger button is slid backwards until theimplant or stent is released.)

As illustrated in FIG. 22, the delivery device 110 may then be retractedand the insertion sleeve 140 can be removed from the anterior chamber 32with the implant 120 remaining within the eye 10 and implanted in thesuprachoroidal space 34.

In some embodiments, the operator confirms that the implant is in aproper position (i.e., the proximal end rests in the anterior chamberwith an unobstructed inlet) using the operating microscope andgonioprism. The anterior chamber can be irrigated and aspirated withbalanced salt solution (BSS) to remove all viscoelastic. If needed, theposterior edge of the incision is pressed down to facilitatesubstantially complete removal of the viscoelastic. The anterior chambercan then be inflated with saline solution to achieve physiologicpressure, as required.

Delivery Device for Advancing Implant Through Device-Formed CornealIncision

FIGS. 23 and 24 show different views of an implant delivery or insertersystem, instrument or device 210, preloaded with an ocular implant 220,in accordance with some embodiments. The delivery device 210 isconfigured to deliver and position the implant 220 in the suprachoroidalspace 34 of the eye 10. In some embodiments, the delivery method is anab interno procedure. In some embodiments, the implant is deliveredthrough a self-sealing corneal incision formed by a corneal penetrationneedle of the delivery device.

The delivery device 210 can be provided in a sterile packaging forsingle-use operation. For example, a double polythene bag may be usedfor sterility purposes, in combination with a blister packaging tofacilitate use by the operator while still maintaining safe usage.

The delivery device 210 is generally elongate in structure, andgenerally comprises an outer housing and handpiece 222, a removableprotective tube 224, an insertion or corneal penetration needle deviceor assembly 226, a trocar device or assembly 228, a trocar trigger 230,a pusher tube device or assembly 328, a pusher tube trigger 330, atrigger safety clip or device 232 and two pairs of solid glue preformstructures 234 a, 234 b and 334 a, 334 b.

The outer housing 222 is similar to the housing 122 and encloses variouscomponentry of the delivery device 210 and can comprise two housingportions such as a left housing portion 236 a and a right housingportion 236 b, which are attached during fabrication of the deliverydevice 210.

Selected portions of the housing 222 have ergonomic features such as thehand grip area 238 a which has a ribbed texture or the like tofacilitate manual handling by a surgeon, medical operator orpractitioner (a similar hand grip area is provided on the right housingportion 236 b). Various internal structures of the outer housing 222engage the other components of the delivery device 210, as discussedfurther below.

The outer housing 222 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the outer housing 222 comprises a thermoplastic material,such as medical grade polycarbonate (PC) that is gamma stable.

The outer housing 222 can efficaciously dimensioned in various suitablemanners, as required or desired. In one non-limiting embodiment, theouter housing 222 has a length of about 5.60 inches, though otherlengths may also be efficaciously utilized, for example, based on thesize of the user's hand (e.g., from about 4 inches to about 8 inches andany length in between).

The protective cover tube 224 is removably mounted on a portion of theinsertion needle device 226 that extends beyond a distal end of thehousing 222. The protective cover tube 224 is removed before thedelivery device 210 is used. The purpose of the protective cover tube224 is to protect the insertion needle device 226 and the componentstherein during packaging, shipping and travel of the implant preloadeddelivery device 210.

The protective cover tube 224 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the protective cover tube 224 comprises a thermoplastic,such as low density polyethylene (LDPE).

The insertion needle device or assembly 226 generally comprises ancorneal penetration or insertion needle 240 and a support sleeve, memberor element 242 fixedly attached thereto and to the outer housing 222.Optionally, a seal 243 is provided to further protect the innercomponentry of the delivery device 210 from undesirable fluid entrance.Distal portions of the insertion needle 240 and support member orelement 242 are exposed and extend beyond the distal tip of the deliverydevice 210 while proximal portions of the insertion needle 240 andsupport member or element 242 are contained within the outer housing222. Portions of the needle may comprise a hydrophilic or hydrophobiccoating. The insertion needle device 226 is discussed in further detaillater herein.

The trocar device or assembly 228 generally comprises a trocar 244 and atrocar collar or support member or element 246 fixedly attached thereto.The trocar collar 246 is mechanically coupled, connected or attached tothe actuatable trocar trigger 230. A substantial distal portion of thetrocar 244 extends through the insertion needle 240 (and pusher tube)with a distal end portion also extending through the implant 220. Aproximal portion of the trocar 244 and the trocar collar 246 arecontained within the outer housing 222. The trocar device 228 isdiscussed in further detail later herein.

The trocar trigger 230 generally comprises an upper finger or thumbactuatable portion 248 and a lower main body portion 250. The actuatabletrigger portion 248 generally extends above the housing 222 while themain body portion 250 is generally contained within the housing 222.Before use, the trocar trigger 230 is in a rear position and when in useit is utilized to first advance and then retract the trocar 244. Thetrigger main body portion 250 is mechanically coupled, connected orattached to the trocar device 228. The trocar trigger 230 is alsomechanically and/or operatively coupled to the pusher tube trigger 330.The trocar trigger 230 is discussed in further detail later herein.

The pusher tube device or assembly 328 generally comprises a pusher tube344 and a trocar collar or support member or element 346 fixedlyattached thereto. The pusher tube collar 346 is mechanically coupled,connected or attached to the actuable pusher tube trigger 330. Asubstantial distal portion of the pusher tube 344 extends through theinsertion needle 340 with a distal end being positioned proximally ofthe implant 220. A proximal portion of the pusher tube 344 and thepusher tube collar 346 are contained within the outer housing 222. Thepusher tube device 328 is discussed in further detail later herein.

The pusher tube trigger 330 generally comprises an upper portion 348distally proximate to the upper finger or thumb actuable trocar triggerportion 248 and a lower main body portion 350. The upper portion 348generally extends above the housing 222 while the main body portion 350is generally contained within the housing 222. Before use, the pushertube trigger 330 is in a rear position and when in use it is utilized toadvance the pusher tube 344 (and the implant 220). The trigger main bodyportion 350 is mechanically coupled, connected or attached to the pushertube device 328. The pusher tube trigger 330 is also mechanically and/oroperatively coupled to the trocar trigger 230. The pusher tube trigger330 is discussed in further detail later herein.

The trigger safety clip 232 is removable and is positioned generallyforwardly with respect to the pusher tube trigger 330 and ismechanically coupled or engaged with the pusher tube trigger 330. Insome embodiments, the trigger safety clip 232 prevents undesirablemotion of the pusher tube trigger 330 and the trocar trigger 230 duringpackaging, shipping and travel of the implant preloaded delivery device210. The trigger safety clip 232 is substantially the same in structureas the trigger safety clip 132 discussed above, and as such thisstructure is not discussed in much further detail herein.

The glue blocks or preforms 234 a, 234 b and 334 a, 334 b are mounted oneach side of the trocar trigger 230 and the pusher tube trigger 330respectively, and within the outer housing 222. The glue blocks orstructures 234 a, 234 b and 334 a, 334 b advantageously provide a safetyfunction to disallow reuse of the delivery device 210 so as to preventany cross-contamination between unauthorized reuse of the single usedevice 210. As discussed further below, the glue blocks 234 a, 234 b and334 a, 334 b are configured to melt when any unapproved re-sterilizationof the delivery device 210 is attempted and lock or jam the trocartrigger 230 and the pusher tube trigger 330 so that their movement isthwarted. In some embodiments, a hot melt adhesive is used to freeze thetrigger mechanism and prevent use after autoclave.

The implant 220 has an implant body 251 with a proximal sleeve 252 andis located within a distal end portion of the insertion needle 240 whenthe delivery device 210 is preloaded with the implant during packaging,storage and before use. The implant 220 is substantially the same instructure as the implant 120 discussed above, and as such this structureis not discussed in much further detail herein.

FIGS. 25-40 show different views of the insertion or corneal penetrationneedle device or assembly 226 and insertion or corneal penetrationneedle 240 in accordance with some embodiments. The insertion needle 240is a generally elongated tubular structure with a lumen 262 extendingtherethrough and a distal curved or non-linear portion 264 to desirablyfacilitate ab interno suprachoroidal implantation. The insertion needle240 has a distal end cutting tip 265 which allows corneal penetration bythe device to desirably form a self-sealing incision. The cutting tip265 is advantageously sized, shaped and dimensioned to form such aself-sealing incision.

The insertion needle support 242 is an elongated member through which aportion of the needle 240 extends and is attached thereto. The insertionneedle support 242 includes a collar 266 which mates with acorresponding portion of the outer housing 222 to fixedly attach thesestructures.

The seal 243 is mounted on a proximal end portion of the insertionneedle 240. The seal 243 may advantageously protect the innercomponentry of the delivery device 210 from undesirable fluid entranceand engages an internal structure of the device 210 and/or housing 222.The insertion needle 240 may comprise a hydrophilic or hydrophobiccoating along at least a portion of its length.

The insertion needle 240 receives a portion of the pusher tube 344 thatpasses through the needle lumen 262 and contains the preloaded implant220 distal of the pusher tube 344, which in turn receives a portion ofthe trocar 244. The needle distal curved or non-linear portion 264advantageously provides proper curvature and alignment of the trocar 244and the implant 220 for suprachoroidal implantation.

The insertion needle device 226 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the insertion sleeve 240 and sleeve support 242 comprisestainless steel and are welded (spot or continuous) to form theassembly, and the seal 243 can comprise silicone or the like. Theinsertion or corneal penetration needle 240 can efficaciously comprise25±5 gauge hypodermic tubing, as required or desired, including, 20, 21,22, 23, 24, 25, 26, 27, 28, 29 and 30 gauge.

The insertion needle device 226 can efficaciously be dimensioned invarious suitable manners, as required or desired. In one non-limitingembodiment, the length L₂₅₁ is about 1.22 inches, the curved length L₂₅₂is about 0.3 inches, the diameter D₂₅ is about 0.02 inches, the radiusof curvature R₂₅ is about 1 inch, and the width W₂₆ is about 0.031inches. The radius of curvature R₂₅ can have the same or substantiallythe same radius of curvature as the trocar 244.

FIGS. 31 and 32 show different views of the trocar device or assembly228, in accordance with some embodiments. The trocar 244 is a generallyelongated structure with a curved or non-linear distal portion 268 witha distal-most end 270 which is configured to optimally penetrate oculartissue so as to access the suprachoroidal space 34.

The trocar 244 extends through the trocar collar or support member orelement 246 which is configured to engage the trocar trigger 230, and beadvancable and retractable on actuation of the trigger 230. The curveddistal portion 268 has a predetermined curvature to allow a proper angleof attack to penetrate ocular tissue to provide access for implantationof the implant 220 in the suprachoroidal space 34.

More particularly, a collar portion 247 of the trocar collar 246 ismechanically engaged, coupled, connected or fixedly attached to arecessed portion of the trocar trigger 230. Thus, actuation, advancementor retraction, of the trocar trigger 230 results in movement,advancement and retraction, of the trocar 244.

The trocar device 228 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar 244 comprises a metal or metal alloy such asspring tempered 304 stainless steel with a predetermined flexibility andresilience, and the trocar collar 246 comprises a metal or metal alloysuch as 303 stainless steel with predetermined properties. The trocar244 and trocar collar 246 can be welded together (spot or continuouswelding), or otherwise attached in other suitable manners, for examplemolding and the like, as needed or desired.

The trocar device 228 can efficaciously be dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the radius of curvature R₃₂ of the trocar distal curvedportion 268 is about 1 inch (which generally conforms to the needle's,pusher tube's and implant's radius of curvature and prevents implantcreep and disorientation), the diameter D₃₂ is about 0.006 inches (whichprovides a low tolerance fit within the implant's lumen), the curvedlength L₃₂₁ is about 0.67 inches, the length L₃₂₂ is about 2.1 inches,the overall unbent length of the trocar 244 is about 3.15 inches, theradius of curvature of the trocar distal end tip 270 is in the rangefrom about 0.001 to about 0.003 inches, and the dimension H₃₂ is about0.22 inches. In various embodiments, the radius of curvature R₃₂ of thetrocar distal curved portion 268 can range from 0.4 inches to about 2.2inches.

FIG. 33 shows a different view of the trocar trigger 230, in accordancewith some embodiments. The ergonomic upper finger or thumb touch portion248 has a ribbed texture configuration to facilitate its actuation bythe operator. The lower main body portion 250 has several features thatallow for the operation of the trocar trigger 230.

The trigger body portion 250 comprises a slot, cavity, opening orrecessed portion 271 which mates with and attaches to a portion of thetrocar collar portion 247 thereby effectively coupling and connectingthe trigger 230 and the trocar 244. The trigger body portion 250 alsocomprises multiple pins 274 disposed generally symmetrically on eitherside which slidably engage the internal structure of the housing 222such as the left and right slots therein, one of which slots is depictedby reference numeral 278 b in FIG. 24.

The trigger body portion 250 further comprises slots 276 on each sidewhich respectively receive the glue preformed blocks 234 a and 234 bthat are mounted therein. As noted above, and discussed further herein,these glue blocks melt and lock the trigger 230 to prevent unapproveduse for the safety of the patient. In some embodiments, a hot meltadhesive is used to freeze the trigger mechanism and prevent use afterautoclave.

The trocar trigger 230 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar trigger 230 comprises a plastic or thermoplastic,such as polyethylene.

FIGS. 34 and 35 show different views of the pusher tube device orassembly 328, in accordance with some embodiments. The pusher tube 344is a generally elongated structure with a curved or non-linear distalportion 368.

The pusher tube 344 extends from the pusher tube collar or supportmember or element 346 which is configured to engage the pusher tubetrigger 330, and be advancable on actuation of the trigger 330, anddesirably be lockable thereafter. The curved distal portion 368 has apredetermined curvature to allow a proper angle of attack for the trocar244 to penetrate ocular tissue to provide access for implantation of theimplant 220 in the suprachoroidal space 34.

More particularly, a collar portion 347 of the pusher tube collar 346mechanically engages, couples, connects or fixedly attaches to arecessed portion of the pusher tube trigger 330. Thus, actuation andadvancement of the pusher tube trigger 330 results in movement andadvancement of the pusher tube 344.

The pusher tube device 328 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the pusher tube 344 comprises nitinol tubing, and the pushertube collar 346 comprises nitinol bar stock. The pusher tube 344 andcollar 346 can be welded together (spot or continuous welding), orotherwise attached in other suitable manners, for example molding andthe like, as needed or desired.

The pusher tube device 328 can efficaciously be dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the radius of curvature R₃₅ of the pusher tube distal curvedportion 368 is about 1 inch (which generally conforms to the needle's,trocar's and implant's radius of curvature and prevents implant creepand disorientation), the diameter D₃₅ is about 0.014 inches (whichprovides a low tolerance fit within the needle's lumen), the curvedlength L₃₅₁ is about 0.5 inches, the length L₃₅₂ is about 2.1 inches,and the overall unbent length of the pusher tube 344 is about 2.57inches. In various embodiments, the radius of curvature R₃₅ of thepusher tube distal curved portion 368 can range from 0.4 inches to about2.2 inches.

FIG. 36 shows a different view of the pusher tube trigger 330, inaccordance with some embodiments. The upper trigger portion 348 isdistally disposed of the trocar trigger portion 248 and actuable withmovement of same. The lower main body portion 350 has several featuresthat allow for the operation of the pusher tube trigger 330.

The trigger body portion 350 comprises a slot, cavity, opening orrecessed portion 371 which mates with and attaches to a portion of thepusher tube collar portion 347 thereby effectively coupling andconnecting the trigger 330 and the pusher tube 344. The trigger bodyportion 350 also comprises multiple pins 374 disposed generallysymmetrically on either side which slidably engage the internalstructure of the housing 222 such as the left and right slots therein,one of which slots is depicted by reference numeral 278 b in FIG. 24.

The trigger body portion 350 further comprises slots 376 on each sidewhich respectively receive the glue preformed blocks 334 a and 334 bthat are mounted therein. As noted above, and discussed further herein,these glue blocks melt and lock the trigger 330 to prevent unapproveduse for the safety of the patient.

The pusher tube trigger 330 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the pusher tube trigger 330 comprises a plastic orthermoplastic such as polyethylene.

FIG. 37 is a detailed view illustrating the attachment or mating betweenthe trocar device 228 and the trocar trigger 230 and that between thepusher tube device 328 and the pusher tube trigger 330. In particular,the trocar device collar portion 247 engages and is received within thetrocar trigger recessed portion 271 and the pusher tube collar portion347 engages and is received within the pusher tube trigger recessedportion 371, thereby operatively coupling the trocar 244 with itstrigger and the pusher tube 344 with its trigger.

FIG. 38 illustrates certain exemplary and non-limiting dimensions basedon the positions of the trocar trigger 230 and the pusher tube trigger330. In the upper drawing, both triggers are in the forward position andthe length L₃₈₁ is about 0.002 inches. In the lower drawing, the pushertube trigger 330 is in a fully forward position, and in some embodimentslocked, and the trocar trigger 230 is retracted, and the length L₃₈₂ isabout 0.064 inches.

The delivery device 210 generally comprises, but is not limited to,materials composed of stainless steel, molded plastic and nitinol, amongothers and equivalents thereof.

Methods of Implant Delivery Through Device-Formed Corneal Incision

FIGS. 39-44 illustrate steps or acts of a surgical procedure or methodof implanting the ocular implant 220 in the suprachoroidal space 34 ofthe eye 10 using the implant delivery or inserter system or device 210in accordance with some embodiments. Given the details in the figuresthe surgical method should be self-explanatory, however some textualdescription is provided below.

A surgical microscope and the patient are positioned to provide asubstantially clear visualization of the trabecular meshwork through agonioprism on the nasal side of the eye. The patient's head can betilted as far as practical from the surgeon, and the microscope can betilted toward the surgeon to ensure a proper viewing angle.

The delivery device 210 is removed from its package. The protectivecover tube 224 is carefully removed from the insertion needle and thesafety clip 232 holding the triggers is removed by the operator takingcare that the triggers 230 and 330 are maintained in the rear position.

The gonioprism is placed on the cornea, and the anterior chamber angleis inspected using the gonioprism to ensure a good visualization at thenasal implant location. The gonioprism is then removed.

FIG. 39 illustrates formation of a self-sealing incision 370 by theinsertion or corneal penetration needle 240, and more particularly, thecutting distal end tip 265 of the needle 240 of the delivery device 210,such that a portion of the needle 240 extends into the anterior chamber32. At this stage, both the trocar trigger 230 and the pusher tubetrigger 330 are maintained in the rear position by the operator. (Stateddifferently, a temporal clear corneal incision is made using a sharpcutting tip of the device. If a clear corneal incision has already beenmade, a cohesive viscoelastic may be used to maintain the anteriorchamber before passing the needle 240 through the incision.)

FIG. 40 illustrates forward deployment of the triggers such that theimplant 220 is exposed and advanced within the anterior chamber 32 alongwith the trocar 240 such that the trocar distal end tip 270 extends by apredetermined distance beyond the implant 220. (Stated differently, oncethe insertion needle enters the eye and is past the pupillary margin,the trocar trigger (and as such the pusher tube trigger) are advanced tothe fully forward position exposing the implant or stent and the trocartip 270.)

As illustrated in FIG. 41, the implant 220 is advanced across theanterior chamber 32 and positioned at the implantation site with thetrocar distal end 270 adjacent the fibrous attachment zone 60. At thisstage, both triggers are maintained in the forward position by theoperator, with the pusher tube trigger 330 desirably locked in positionso that the implant 220 cannot be proximally displaced. The angle ofattack θ₄₁ is about 15° (degrees), though 10, 11, 12, 13, 14, 15, 16,17, 18, 19 and 20° (degrees) or other attack angles may efficaciously beutilized, as needed or desired. (Stated differently, the gonioprism isplaced on the cornea, and the trocar/implant are guided across theanterior chamber to the nasal angle. Care is taken to avoid contact withthe lens, cornea and iris. The trocar/implant are advanced to theanterior chamber angle just posterior to the scleral spur.)

Next, as illustrated in FIG. 42, the trocar distal tip or end 270penetrates through the tissue of and/or adjacent the fibrous attachmentzone 60 and the implant 220 is advanced until its implantation positionhas been reached in the suprachoroidal space 34 with a predeterminedportion of the implant sleeve 252 extending into the anterior chamber32. The trocar trigger 230 is maintained in the forward position by theoperator at this stage. (Stated differently, a generally narrow passageis created into the suprachoroidal space by gently separating the irisprocesses away from the scleral spur with the tip of the insertiontrocar until the anterior and posterior portions of the scleral spur aresubstantially fully visible on a limited area—e.g., create anapproximately 0.5 mm to a maximum of about 1 mm width opening. Thetrocar/implant are continued to be advanced along the posterior marginof the scleral spur. With finger or thumb holding the rear/trocartrigger in the forward position, the trocar/implant are carefullyadvanced into the suprachoroidal space until the implant proximal sleevejust passes the scleral spur and enters the suprachoroidal space—in someembodiments, approximately half (or about 0.4 mm to about 0.7 mm) of theimplant sleeve remains in the anterior chamber.

Next, as illustrated in FIG. 43, the trocar trigger 230 is moved in arear or proximal direction 282 by the operator so that the trocar 244 isretracted from the implant lumen and the suprachoroidal space 34.(Stated differently, once the implant or stent is in position at theproper depth, the trocar trigger button is slid backwards until theimplant or stent is released.)

As illustrated in FIG. 44, the delivery device 210 is retracted and theinsertion needle 240 is removed from the anterior chamber 32 with theimplant 220 remaining within the eye 10 and implanted in thesuprachoroidal space 34. The incision 370 desirably self-seals.

In some embodiments, the operator confirms that the implant is in aproper position (i.e., the proximal end rests in the anterior chamberwith an unobstructed inlet) using the operating microscope andgonioprism. The anterior chamber can be irrigated and aspirated withbalanced salt solution (BSS) to remove all viscoelastic, if used. Ifneeded, the posterior edge of the incision is pressed down to facilitatesubstantially complete removal of the viscoelastic, if used. Theanterior chamber can then be inflated with saline solution to achievephysiologic pressure, as required.

Drugs and Therapeutic Agents

In some embodiments, the implants disclosed herein can provide fordelivery of a therapeutic agent or drug. The therapeutic agent can be,for example, an intraocular pressure-lowering drug. In some embodiments,the therapeutic agent or drug is introduced concurrently with thedelivery of the shunt to the eye. The therapeutic agent or drug can bepart of the implant itself. For example, the therapeutic agent or drugcan be embedded in the material of the shunt, or coat at least a portionof the implant. The therapeutic agent or drug may be present on variousportions of the implant. For example, the therapeutic agent or drug maybe present on the distal end of the implant, or the proximal end of theimplant. The implant can include combination of therapeutic agents ordrugs. The different therapeutic agents or drugs can be separated orcombined. One kind of therapeutic agent or drug can be present at theproximal end of the implant, and a different kind of therapeutic agentor drug can be present at the distal end of the implant. For example, ananti-proliferative agent may be present at the distal end of the implantto prevent growth, and a growth-promoting agent may be applied to theproximal end of the implant to promote growth.

Examples of drugs may include various anti-secretory agents;antimitotics and other anti-proliferative agents, including amongothers, anti-angiogenesis agents such as angiostatin, anecortaveacetate, thrombospondin, VEGF receptor tyrosine kinase inhibitors andanti-vascular endothelial growth factor (anti-VEGF) drugs such asranibizumab (LUCENTIS®) and bevacizumab (AVASTIN®), pegaptanib(MACUGEN®), sunitinib and sorafenib and any of a variety of knownsmall-molecule and transcription inhibitors having anti-angiogenesiseffect (additional non-limiting examples of such anti-VEGF compounds aredescribed in U.S. Patent Application Publication No. 2008/0228127, theentire content of which is incorporated herein by reference); classes ofknown ophthalmic drugs, including: glaucoma agents, such as adrenergicantagonists, including for example, beta-blocker agents such asatenolol, propranolol, metipranolol, betaxolol, carteolol,levobetaxolol, levobunolol and timolol; adrenergic agonists orsympathomimetic agents such as epinephrine, dipivefrin, clonidine,aparclonidine, and brimonidine; parasympathomimetics or cholingericagonists such as pilocarpine, carbachol, phospholine iodine, andphysostigmine, salicylate, acetylcholine chloride, eserine, diisopropylfluorophosphate, demecarium bromide); muscarinics; carbonic anhydraseinhibitor agents, including topical and/or systemic agents, for exampleacetozolamide, brinzolamide, dorzolamide and methazolamide,ethoxzolamide, diamox, and dichlorphenamide; mydriatic-cycloplegicagents such as atropine, cyclopentolate, succinylcholine, homatropine,phenylephrine, scopolamine and tropicamide; prostaglandins such asprostaglandin F2 alpha, antiprostaglandins, prostaglandin precursors, orprostaglandin analog agents such as bimatoprost, latanoprost, travoprostand unoprostone.

Other examples of drugs may also include anti-inflammatory agentsincluding for example glucocorticoids and corticosteroids such asbetamethasone, cortisone, dexamethasone, dexamethasone 21-phosphate,methylprednisolone, prednisolone 21-phosphate, prednisolone acetate,prednisolone, fluorometholone, loteprednol, medrysone, fluocinoloneacetonide, triamcinolone acetonide, triamcinolone, beclomethasone,budesonide, flunisolide, fluticasone, hydrocortisone, hydrocortisoneacetate, loteprednol, rimexolone and non-steroidal anti-inflammatoryagents including, for example, diclofenac, flurbiprofen, ibuprofen,bromfenac, nepafenac, and ketorolac, salicylate, indomethacin,ibuprofen, naxopren, piroxicam and nabumetone; anti-infective orantimicrobial agents such as antibiotics including, for example,tetracycline, chlortetracycline, bacitracin, neomycin, polymyxin,gramicidin, cephalexin, oxytetracycline, chloramphenicol, rifampicin,ciprofloxacin, tobramycin, gentamycin, erythromycin, penicillin,sulfonamides, sulfadiazine, sulfacetamide, sulfamethizole,sulfisoxazole, nitrofurazone, sodium propionate, aminoglycosides such asgentamicin and tobramycin; fluoroquinolones such as ciprofloxacin,gatifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin;bacitracin, erythromycin, fusidic acid, neomycin, polymyxin B,gramicidin, trimethoprim and sulfacetamide; antifungals such asamphotericin B and miconazole; antivirals such as idoxuridinetrifluorothymidine, acyclovir, gancyclovir, interferon; antimicotics;immune-modulating agents such as antiallergenics, including, forexample, sodium chromoglycate, antazoline, methapyriline,chlorpheniramine, cetrizine, pyrilamine, prophenpyridamine;anti-histamine agents such as azelastine, emedastine and levocabastine;immunological drugs (such as vaccines and immune stimulants); MAST cellstabilizer agents such as cromolyn sodium, ketotifen, lodoxamide,nedocrimil, olopatadine and pemirolastciliary body ablative agents, suchas gentimicin and cidofovir; and other ophthalmic agents such asverteporfin, proparacaine, tetracaine, cyclosporine and pilocarpine;inhibitors of cell-surface glycoprotein receptors; decongestants such asphenylephrine, naphazoline, tetrahydrazoline; lipids or hypotensivelipids; dopaminergic agonists and/or antagonists such as quinpirole,fenoldopam, and ibopamine; vasospasm inhibitors; vasodilators;antihypertensive agents; angiotensin converting enzyme (ACE) inhibitors;angiotensin-1 receptor antagonists such as olmesartan; microtubuleinhibitors; molecular motor (dynein and/or kinesin) inhibitors; actincytoskeleton regulatory agents such as cyctchalasin, latrunculin,swinholide A, ethacrynic acid, H-7, and Rho-kinase (ROCK) inhibitors;remodeling inhibitors; modulators of the extracellular matrix such astert-butylhydro-quinolone and AL-3037A; adenosine receptor agonistsand/or antagonists such as N-6-cylclophexyladenosine and(R)-phenylisopropyladenosine; serotonin agonists; hormonal agents suchas estrogens, estradiol, progestational hormones, progesterone, insulin,calcitonin, parathyroid hormone, peptide and vasopressin hypothalamusreleasing factor; growth factor antagonists or growth factors,including, for example, epidermal growth factor, fibroblast growthfactor, platelet derived growth factor or antagonists thereof,transforming growth factor beta, somatotrapin, fibronectin, connectivetissue growth factor, bone morphogenic proteins (BMPs); cytokines suchas interleukins, CD44, cochlin, and serum amyloids, such as serumamyloid A.

Other therapeutic agents may include neuroprotective agents such aslubezole, nimodipine and related compounds, and including blood flowenhancers such as dorzolamide or betaxolol; compounds that promote bloodoxygenation such as erythropoeitin; sodium channels blockers; calciumchannel blockers such as nilvadipine or lomerizine; glutamate inhibitorssuch as memantine nitromemantine, riluzole, dextromethorphan oragmatine; acetylcholinsterase inhibitors such as galantamine;hydroxylamines or derivatives thereof, such as the water solublehydroxylamine derivative OT-440; synaptic modulators such as hydrogensulfide compounds containing flavonoid glycosides and/or terpenoids,such as ginkgo biloba; neurotrophic factors such as glial cell-linederived neutrophic factor, brain derived neurotrophic factor; cytokinesof the IL-6 family of proteins such as ciliary neurotrophic factor orleukemia inhibitory factor; compounds or factors that affect nitricoxide levels, such as nitric oxide, nitroglycerin, or nitric oxidesynthase inhibitors; cannabinoid receptor agonsists such as WIN55-212-2,free radical scavengers such as methoxypolyethylene glycol thioester(MPDTE) or methoxypolyethlene glycol thiol coupled with EDTA methyltriester (MPSEDE); anti-oxidants such as astaxathin, dithiolethione,vitamin E, or metallocorroles (e.g., iron, manganese or galliumcorroles); compounds or factors involved in oxygen homeostasis such asneuroglobin or cytoglobin; inhibitors or factors that impactmitochondrial division or fission, such as Mdivi-1 (a selectiveinhibitor of dynamin related protein 1 (Drp1)); kinase inhibitors ormodulators such as the Rho-kinase inhibitor H-1152 or the tyrosinekinase inhibitor AG1478; compounds or factors that affect integrinfunction, such as the Beta 1-integrin activating antibody HUTS-21;N-acyl-ethanaolamines and their precursors, N-acyl-ethanolaminephospholipids; stimulators of glucagon-like peptide 1 receptors (e.g.,glucagon-like peptide 1); polyphenol containing compounds such asresveratrol; chelating compounds; apoptosis-related protease inhibitors;compounds that reduce new protein synthesis; radiotherapeutic agents;photodynamic therapy agents; gene therapy agents; genetic modulators;auto-immune modulators that prevent damage to nerves or portions ofnerves (e.g., demyelination) such as glatimir; myelin inhibitors such asanti-NgR Blocking Protein, NgR(310)ecto-Fc; other immune modulators suchas FK506 binding proteins (e.g., FKBP51); and dry eye medications suchas cyclosporine A, delmulcents, and sodium hyaluronate.

Other therapeutic agents that may be used include: other beta-blockeragents such as acebutolol, atenolol, bisoprolol, carvedilol, asmolol,labetalol, nadolol, penbutolol, and pindolol; other corticosteroidal andnon-steroidal anti-inflammatory agents such aspirin, betamethasone,cortisone, diflunisal, etodolac, fenoprofen, fludrocortisone,flurbiprofen, hydrocortisone, ibuprofen, indomethacine, ketoprofen,meclofenamate, mefenamic acid, meloxicam, methylprednisolone,nabumetone, naproxen, oxaprozin, prednisolone, prioxicam, salsalate,sulindac and tolmetin; COX-2 inhibitors like celecoxib, rofecoxib and.Valdecoxib; other immune-modulating agents such as aldesleukin,adalimumab (HUMIRA®), azathioprine, basiliximab, daclizumab, etanercept(ENBREL®), hydroxychloroquine, infliximab (REMICADE®), leflunomide,methotrexate, mycophenolate mofetil, and sulfasalazine; otheranti-histamine agents such as loratadine, desloratadine, cetirizine,diphenhydramine, chlorpheniramine, dexchlorpheniramine, clemastine,cyproheptadine, fexofenadine, hydroxyzine and promethazine; otheranti-infective agents such as aminoglycosides such as amikacin andstreptomycin; anti-fungal agents such as amphotericin B, caspofungin,clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole,terbinafine and nystatin; anti-malarial agents such as chloroquine,atovaquone, mefloquine, primaquine, quinidine and quinine;anti-mycobacterium agents such as ethambutol, isoniazid, pyrazinamide,rifampin and rifabutin; anti-parasitic agents such as albendazole,mebendazole, thiobendazole, metronidazole, pyrantel, atovaquone,iodoquinaol, ivermectin, paromycin, praziquantel, and trimatrexate;other anti-viral agents, including anti-CMV or anti-herpetic agents suchas acyclovir, cidofovir, famciclovir, gangciclovir, valacyclovir,valganciclovir, vidarabine, trifluridine and foscarnet; proteaseinhibitors such as ritonavir, saquinavir, lopinavir, indinavir,atazanavir, amprenavir and nelfinavir;nucleotide/nucleoside/non-nucleoside reverse transcriptase inhibitorssuch as abacavir, ddI, 3TC, d4T, ddC, tenofovir and emtricitabine,delavirdine, efavirenz and nevirapine; other anti-viral agents such asinterferons, ribavirin and trifluridiene; other anti-bacterial agents,including cabapenems like ertapenem, imipenem and meropenem;cephalosporins such as cefadroxil, cefazolin, cefdinir, cefditoren,cephalexin, cefaclor, cefepime, cefoperazone, cefotaxime, cefotetan,cefoxitin, cefpodoxime, cefprozil, ceftaxidime, ceftibuten, ceftizoxime,ceftriaxone, cefuroxime and loracarbef; other macrolides and ketolidessuch as azithromycin, clarithromycin, dirithromycin and telithromycin;penicillins (with and without clavulanate) including amoxicillin,ampicillin, pivampicillin, dicloxacillin, nafcillin, oxacillin,piperacillin, and ticarcillin; tetracyclines such as doxycycline,minocycline and tetracycline; other anti-bacterials such as aztreonam,chloramphenicol, clindamycin, linezolid, nitrofurantoin and vancomycin;alpha blocker agents such as doxazosin, prazosin and terazosin;calcium-channel blockers such as amlodipine, bepridil, diltiazem,felodipine, isradipine, nicardipine, nifedipine, nisoldipine andverapamil; other anti-hypertensive agents such as clonidine, diazoxide,fenoldopan, hydralazine, minoxidil, nitroprusside, phenoxybenzamine,epoprostenol, tolazoline, treprostinil and nitrate-based agents;anti-coagulant agents, including heparins and heparinoids such asheparin, dalteparin, enoxaparin, tinzaparin and fondaparinux; otheranti-coagulant agents such as hirudin, aprotinin, argatroban,bivalirudin, desirudin, lepirudin, warfarin and ximelagatran;anti-platelet agents such as abciximab, clopidogrel, dipyridamole,optifibatide, ticlopidine and tirofiban; prostaglandin PDE-5 inhibitorsand other prostaglandin agents such as alprostadil, carboprost,sildenafil, tadalafil and vardenafil; thrombin inhibitors;antithrombogenic agents; anti-platelet aggregating agents; thrombolyticagents and/or fibrinolytic agents such as alteplase, anistreplase,reteplase, streptokinase, tenecteplase and urokinase; anti-proliferativeagents such as sirolimus, tacrolimus, everolimus, zotarolimus,paclitaxel and mycophenolic acid; hormonal-related agents includinglevothyroxine, fluoxymestrone, methyltestosterone, nandrolone,oxandrolone, testosterone, estradiol, estrone, estropipate, clomiphene,gonadotropins, hydroxyprogesterone, levonorgestrel, medroxyprogesterone,megestrol, mifepristone, norethindrone, oxytocin, progesterone,raloxifene and tamoxifen; anti-neoplastic agents, including alkylatingagents such as carmustine lomustine, melphalan, cisplatin,fluorouracil3, and procarbazine antibiotic-like agents such asbleomycin, daunorubicin, doxorubicin, idarubicin, mitomycin andplicamycin; anti proliferative agents (such as 1,3-cis retinoic acid,5-fluorouracil, taxol, rapamycin, mitomycin C and cisplatin);antimetabolite agents such as cytarabine, fludarabine, hydroxyurea,mercaptopurine and 5-fluorouracil (5-FU); immune modulating agents suchas aldesleukin, imatinib, rituximab and tositumomab; mitotic inhibitorsdocetaxel, etoposide, vinblastine and vincristine; radioactive agentssuch as strontium-89; and other anti-neoplastic agents such asirinotecan, topotecan and mitotane.

In some embodiments, the therapeutic agent is delivered through theimplant to the desired location in the eye, such as the suprachoroidalspace of the uveoscleral outflow pathway. In some embodiments, thetherapeutic agent is delivered to the suprachoroidal space of theuveoscleral outflow pathway in combination with a therapeutic agentdelivered via trans pars plana vitrectomy, thereby delivering atherapeutic agent to both sides of the retina. In some embodiments, theimplant can improve access of topical medication to the posterior uvea.In some embodiments, the implant is used to deliver a topical medicationto treat a chorio-retinal disease.

Comparisons of Certain Implant Delivery Technologies

In some embodiments, the delivery device 110 provides implantationthrough a preformed or prior corneal incision while the delivery device210 does so through a self-created and self-sealing incision such that a“closed chamber” operation is performed.

The delivery device 110 is configured, in some embodiments, so that theimplant is supported on a trocar wire or obturator in an exposedconfiguration. In some embodiments, the delivery device 210 supports theimplant on a trocar wire or obturator within an insertion or cornealpenetration needle.

In some embodiments, the delivery device 110 comprises a siliconeretainer to hold the implant in place during travel. The delivery device210, in some embodiments, incorporates a curved delivery system thatprovides adequate side loads and friction to hold the implant in placeduring travel and shipping.

The delivery device 110, in certain embodiments, employs a singletrigger operation to release the implant. The delivery device 210, inaccordance with some embodiments, utilizes a dual trigger operation toexpose and release the implant—trocar and implant pusher tube triggers.Once the insertion needle penetrates the cornea, both triggers advanceto expose the implant or stent and the trocar and obturator. The frontpusher tube trigger locks the pusher tube in a forward position, therebypreventing the implant or stent from retracting back into the needle.After implant or stent implantation, the rear trocar trigger isretracted to retract the trocar and release the implant or stent.

Some Desirable Features and Advantages

It should be appreciated, in accordance with some embodiments, that thedisclosed implant is prevented from backward movement basedadvantageously on the delivery device configuration. For example, theimplant 120 is prevented from backward movement because of the insertionsleeve's distal end relative dimensioning and the implant 220 isprevented from backward movement because of pusher tube's distal endrelative dimensioning.

Moreover, because of the material properties of the disclosed trocars,creep during shelf life should advantageously not be an issue ofconcern. Also, in accordance with some embodiments, given that theimplants and trocars are asymmetrically curved, this orientation aspackaged, prevents any undesirable rotation of the implants with respectto the trocars even when in use. Furthermore, in accordance with someembodiments, at least the implants and trocars have predeterminedcurvatures which, because of their selected flexibility, can conform tothe particular space or ocular location they are inserted or advancedinto.

In some embodiments, the delivery device 110 is configured for use incombination with another ocular surgery, such as cataract surgery. Thedelivery device 110 can include a preloaded implant 120 and have apre-curved tip. The device 110 advantageously has an ergonomichandpiece.

In some embodiments, the delivery device 210 is configured forstand-alone, in-office surgery without being performed in conjunctionwith other ocular surgery (e.g., cataract surgery). The delivery device210 can include a preloaded implant 220 and can have a pre-curved tip.Also, in some embodiments, the device 210 has integrated cornealpenetration and closed chamber capability so as to perform the procedurethrough a self-sealing incision. The device 210 advantageously includesan ergonomic handpiece.

Certain embodiments provide for the implant, trocar and/or the pushertube to flex and allow for the implant to conform to the anatomy of thesuprachoroidal space.

The delivery device geometries, such as with respect to the attack angleand curvature, can advantageously ensure proper placement of the implantin the suprachoroidal space, supraciliary space, or other anatomicalspace.

In some embodiments, the low friction (polyethylene on polycarbonate)trigger operation, in accordance with some embodiments, advantageouslyallows for smooth operation during the delivery procedures. The safetyclips may advantageously prevent undesirable trigger motion duringshipment and transportation of the delivery devices.

Embodiments of the trocar or obturator material and tip shape provideseveral advantages which include: use of high temper stainless springsteel; pointed enough tip to pierce ciliary muscle attachment; roundedenough tip to prevent irritation/tissue damage in suprachoroidal spaceat sclera/choroid; material and shape allows constant force againstsclera during advancement in order to assure proper placement of implantwithin suprachoroidal space; and trocar curvature generally matchesimplant or stent shape to prevent plastic creep during shelf life.

With respect to embodiments of the delivery device 210, the curved,flared and coated stainless steel insertion or corneal penetrationneedle is advantageously shaped to fit anatomically within eye the andavoid iris touch. Also, the tight corneal incision can minimize fluidloss from the eye by forming a substantially closed chamber self-sealingentry. Moreover, the lowered sliding friction of the needle shaft oncein the eye may advantageously prevent movement during this delicatesurgery, and any resultant loss of view during any interoperativegonioscopy.

In some embodiments, and once again with respect to embodiments of thedelivery device 210, the superelastic nitinol pusher tube providesbackup support for the implant or stent during implantation, and allowsminimal sliding force during trigger operation. Also, in accordance withsome embodiments, the polyethylene protective tube prevents damage tothe needle tip during shipment.

The delivery device 210, in accordance with some embodiments, canadvantageously be used in “closed chamber” procedure so that: noviscoelastic is required to inflate the anterior chamber; there isminimal loss of fluid from anterior chamber (this reduces chance ofhypotony; no separate blade is required to form the corneal incision;results in faster surgery; there is only one time entry into the eye; asafer procedure with less chance or lowered probability for adverseevent (e.g., endophthalmitis); and less expensive and more costeffective.

The curved insertion needle, trocar or obturator, and pusher tube of thedelivery device 210 also, in certain embodiments allows for retention ofthe implant or stent shape during shipping to prevent creep (such as,loss of implant or stent curvature). Moreover, the closed-chamberprocedure can allow for enhanced surgical safety in a non-deepenedanterior chamber by substantially matching the curvature of cornea andallowing traversing of the eye in an ab interno procedure.

Methods

The methods which are described and illustrated herein are not limitedto the sequence of acts described, nor are they necessarily limited tothe practice of all of the acts set forth. Other sequences of acts, orless than all of the acts, or simultaneous occurrence of the acts, maybe utilized in practicing embodiments of the invention(s).

Ranges

It is to be understood that any range of values disclosed, taught orsuggested herein comprises all values and sub-ranges therebetween. Forexample, a range from 5 to 10 will comprise all numerical values between5 and 10 and all sub-ranges between 5 and 10.

CONCLUSION

From the foregoing description, it will be appreciated that a novelapproach for intraocular pressure control has been disclosed. While thecomponents, techniques and aspects of embodiments of the invention havebeen described with a certain degree of particularity, it is manifestthat many changes may be made in the specific designs, constructions andmethodology herein above described without departing from the spirit andscope of this disclosure.

While a number of preferred embodiments of the invention and variationsthereof have been described in detail, other modifications and methodsof using and medical, diagnostic, research and therapeutic applicationsfor the same will be apparent to those of skill in the art. Accordingly,it should be understood that various applications, modifications, andsubstitutions may be made of equivalents without departing from thespirit of embodiments of the invention or the scope of the claims.

Various modifications and applications of the embodiments of theinvention may occur to those who are skilled in the art, withoutdeparting from the true spirit or scope of the embodiments of theinvention. It should be understood that the invention(s) is not limitedto the embodiments set forth herein for purposes of exemplification, butis to be defined only by a fair reading of the appended claims,including the full range of equivalency to which each element thereof isentitled.

What is claimed is:
 1. An ocular implant delivery device, comprising: agenerally elongated outer housing and handpiece that is ergonomicallycontoured; an elongated insertion needle partially disposed in the outerhousing and having a non-linear exposed distal portion; an implantpusher tube extending through a lumen of the insertion needle and havinga non-linear distal portion; a trocar passing through a lumen of thepusher tube and having a non-linear distal portion; an implant disposedon the non-linear portion of the trocar and being positioned within thenon-linear portion of the insertion needle; a pusher tube triggermechanically coupled to the pusher tube; and a trocar triggermechanically coupled to the trocar and being configured such thatactuation of the trocar trigger in a first direction advances a distaltip of the trocar distally away from the housing and actuation of thetrocar trigger in a second direction retracts the distal tip of thetrocar proximally toward the housing, the trocar trigger further beingconfigured such that actuation of the trocar trigger in the firstdirection moves the pusher tube trigger.
 2. The delivery device of claim1, wherein the insertion needle is configured to create a self-sealingcorneal incision having a size of about 1 mm or less.
 3. The deliverydevice of claim 1, wherein the non-linear portions of the insertionneedle, pusher tube and trocar have a substantially matching curvature.4. The delivery device of claim 3, wherein the implant has a curvaturethat substantially conforms to the curvatures of the insertion needle,pusher tube and trocar.
 5. The delivery device of claim 1, wherein thepusher tube trigger is mechanically coupled to the trocar trigger. 6.The delivery device of claim 5, wherein the trocar is advancable andretractable by moving the trocar trigger longitudinally along theelongate housing.
 7. The delivery device of claim 1, wherein, when fullyadvanced, the pusher tube is locked to prevent further motion.
 8. Thedelivery device of claim 1, wherein the delivery device is configuredfor single-use operation.
 9. The delivery device of claim 1, whereinactuation of the trocar trigger in the first direction causes theimplant to be exposed for implantation in a suprachoroidal space of aneye.
 10. A method of implanting a suprachoroidal implant, comprising:forming a self-sealing corneal incision using an insertion needle of animplant delivery device; actuating a trocar trigger to actuate a pushertube trigger and advance an implant and a trocar into an anteriorchamber of an eye, wherein the implant is located on a distal portion ofthe trocar, and wherein the implant and the distal portion of the trocarhave substantially the same curvature; positioning a distal tip of thetrocar adjacent a suprachoroidal space of the eye; penetrating oculartissue using the distal tip of the trocar and locating the implant inthe suprachoroidal space; and retracting the trocar from within theimplant by actuating the trocar trigger.
 11. The method of claim 10,wherein a pusher tube is used to move the implant from within theinsertion needle and expose it for implantation.
 12. The method of claim10, wherein the trocar trigger is mechanically coupled to a pusher tubetrigger.
 13. The method of claim 10, wherein the method furthercomprises at least one of draining fluid from the anterior chamber andeluting a therapeutic agent using the implant.
 14. The method of claim10, wherein the distal portion of the trocar, the implant and a distalportion of the insertion needle all have substantially matchingcurvatures.
 15. The method of claim 14, wherein a distal portion of animplant pusher tube has substantially the same curvature as the distalportions of the trocar and the insertion needle and as the implant. 16.The method of claim 10, wherein the insertion needle comprises a 25±5gauge needle.